Surgical instrument with pivotable implant holder

ABSTRACT

A surgical instrument for inserting an implant is shown. The instrument has a housing having a first end and a second end, a rotatable drive member having an elongated member comprising a grip that is associated with the first end, an implant holder having a securing member that extends through the second end and that is adapted to receive and hold the implant. A universal joint couples the implant holder and the elongated member and is adapted to permit a user to rotatably drive the implant holder when the implant holder is in a pivoted position.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a surgical implant instrument and system and,more particularly, to an instrument and system having an implant holderhaving a joint that is adapted to permit the implant holder to beloosened, moved or pivoted to a desired position and tightened before,during and after such movement or pivoting.

2. Background of the Invention

In the past, surgical instruments were provided for applying orinserting implants between adjacent vertebrae in a vertebral column. Theimplant was positioned or fixed at the end of the instrument usually ina fixed or rigidly connected position.

In some prior art instruments, the tool permitted a variable adjustablealignment of the implant in relation to the instrument. For example,some instruments had a non-pivotable threaded screw that screweddirectly into the implant and held the implant in a fixed position atthe end of the instrument. In one prior art device, the implant had apivotable threaded sleeve that permitted the implant to be pivotedrelative to an end of the instrument.

In U.S. Pat. No. 6,830,574 B2, another prior art instrument is shownhaving a holder that is pivotably mounted relative to a shank and isfixable in its position.

One problem with the prior art devices is their complexity and that theyeither did not permit pivoting of the implant or required multiplecomponents to permit the implant to be pivoted and separate componentsto fix the implant to the instrument after the implant was pivoted tothe desired position.

Another problem with some prior art devices was that the cage implanthad to be custom fit to the holder and standard cage implants could notbe used. These custom cages oftentimes required an attaching joint thatreduced or interfered with the graft space in the case because of thejoint in the cage or implant.

What is needed, therefore, is a simplified instrument that is easy touse, improves over the designs of the prior art and/or reduces thenumber of components necessary to enable a user or surgeon to pivot theimplant with respect to the tool and then fix the position of theimplant with respect to the tool.

SUMMARY OF THE INVENTION

It is, therefore, an object of one embodiment of the invention toprovide a surgical instrument and system that is adapted for fixing toan implant and that permits a loosening of the implant for adjustment,movement or pivoting and then a tightening of the implant on thesurgical instrument once the implant is positioned where desired.

Another object of one embodiment of the invention is to provide asurgical instrument and system that utilizes a single device or meansfor loosening and pivoting the implant and then fixing, locking orclamping the implant to the tool.

Still another object of one embodiment of the invention is to provide asurgical instrument having a universal joint that provides a connectoror driving connection that permits the implant holder to be both pivotedand rotated before, during and after pivoting.

Yet another object of one embodiment of the invention is to provide asystem having a surgical instrument that is adapted to permit a threadedprojection to be secured to an implant, loosened, and pivoted and thatis also adapted to rotatably drive the threaded projection prior to,during and after the pivoting of the threaded projection or implant.

Another object of an embodiment of the invention is to provide asurgical instrument having a single rotatable drive member or grip thatis adapted to permit both a pivoting of an implant on the instrument anda locking, clamping, securing or fixing of the implant to the surgicalinstrument after it has been moved or pivoted to a desired position.

Another object of an embodiment of the invention is to provide auniversal joint for use in a surgical instrument wherein the universaljoint is adapted to permit multiple functions, including pivoting androtating of an implant holder, to facilitate securing, locking, fixingor clamping of an implant to the instrument.

Another object of another embodiment of the invention is to provide animplant holder that has a pivot joint in the holder and that is adaptedto permit a standardized cage to be used.

In one aspect, one embodiment of the invention comprises a surgicalinstrument for inserting an implant comprising a housing having a firstend and a second end, a rotatable member rotatably positioned in thehousing, the rotatable member having an elongated member comprising agrip associated with the first end, an implant holder having a securingmember that extends through the second end and that is adapted toreceive and hold the implant; and a universal joint coupling the implantholder and the elongated member, and the universal joint being situatedbetween the grip and the implant holder, the universal joint beingadapted to permit a user to rotatably drive the implant holder when theimplant holder is in a pivoted position.

In another aspect, another embodiment of the invention comprises asurgical implant system comprising an implant, a surgical instrumentcomprising a housing, a drive member rotatably mounted within thehousing, an implant holder, a joint rotatably and pivotally coupling thedrive member to the implant holder, the joint being adapted to permit aloosing of the implant on the implant holder so that the implant holdermay be pivoted or moved to a desired position and being responsive torotational movement of the drive member to enable said implant to beloosened and pivoted and to cause the implant to become clamped, fixedor locked to the implant holder after the implant holder is pivoted ormoved to the desired position.

These and other objects and advantages of the invention will be apparentfrom the following description, the accompanying drawings and theappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D are various views of a surgical instrument and system inaccordance with one embodiment of the invention;

FIGS. 2A and 2B are sectional and exploded views, respectively, of theembodiment shown in FIGS. 1A-1D;

FIG. 3A is a fragmentary and partially exploded view illustrating thedevice or means for pivotably affixing or securing an abutment member toa housing of the surgical instrument;

FIG. 3B is a fragmentary view of an end of the housing, showing teeth orserrations;

FIG. 4 is a fragmentary sectional view showing various details of auniversal joint used in the embodiments shown in FIGS. 1-3B;

FIG. 5 is an exploded view showing various details of the universaljoint used in one embodiment of the invention;

FIG. 6 is an exploded sectional view showing various details of theuniversal joint housing and abutment member illustrated in FIG. 5;

FIGS. 7A-7F are various sectional and fragmentary views that cooperateto show a pivotable movement of an implant holder and then a fixing,clamping or securing and locking of the implant to the implant holderafter it has been pivoted and further showing the implant being clamped,fixed, locked or fastened in a pivoted position;

FIG. 8A is a fragmentary sectional view of a ball of the universal jointshowing a butterfly or bow tie channel or aperture in one embodiment ofthe invention;

FIG. 8B is a view diagrammatically illustrating or outlining thebutterfly or bow tie channel or aperture in the ball of the universaljoint; and

FIGS. 9A-9D are fragmentary sectional views illustrating a rotatablemovement of a fastener or threaded projection during a pivot of athreaded projection, thereof.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to FIGS. 1-9D, a surgical instrument and system 10 areshown. The surgical instrument and system 10 comprises an implant 12 anda surgical instrument 14 for inserting the implant 12 into a patient. Inone illustrative embodiment, the implant 12 is an intervertebral cageand the surgical instrument 14 adapted to insert the intervertebral cagein a disk area (not shown) between a pair of adjacent vertebrae (notshown). In general, one embodiment enables or permits the implant 12 tobe mounted on the instrument (e.g., as shown in FIGS. 1A and 1C) andpivoted or moved to a pivoted or desired position (e.g., as shown inFIGS. 1B and 1D). The invention permits loosening and tightening of theimplant 12 to the instrument before, during, after and through suchpivotal movement.

In the illustration being described, the surgical instrument 14comprises a housing 16 which in one illustrative embodiment is tubularand has a first end 16 a and a second end 16 b. The housing 16 has aninner wall 16 c (FIG. 2A) that defines an interior housing area 18 forreceiving a drive member, rotatable member, or rod 20 that is generallyelongated and becomes generally aligned with a longitudinal axis A (FIG.3A) of the surgical instrument 14 when it is received in the housing 16.As shown in FIGS. 2A and 2B, the first end 16 a is tubular and has agenerally circular inner wall 16 c 1 and a generally circular outer wall16 c 2. The second end 16 b is also tubular has a generally circularinner wall 16 c 3 and a generally square outer wall 16 c 4.

A first end 22 a of the grip 22 comprises a radial cylindrical member orshoulder 22 a having an aperture (not shown) for receiving the end 20 aof the drive member, rotatable member or rod 20. The end 20 a may besecured to the cylindrical member or shoulder 22 a of grip 22 byconventional means such as a press fit, weld or adhesive. A set pin 19(FIGS. 2A and 2B) that prevents the drive member, rotatable member orrod 20 from withdrawing from the housing 16. The cylindrical member orshoulder 22 a has a circumference 22 b that is dimensioned to provide abearing surface that cooperates with the inner wall 16 c to keep thedrive member, rotatable member or rod 20 generally aligned in thehousing 16.

FIG. 2A is a sectional view of the instrument 10 and FIG. 2B is anexploded view illustrating various components. The housing 16 comprisesthe first end 16 a having a generally radial wall 24 having an innerwall surface 24 a 1 that defines an opening 25 that is in communicationwith the interior housing area 18. The inner wall surface 24 a 1provides or defines a shoulder or abutment surface that cooperates witha surface 22 a 1 of the radial cylindrical member or shoulder 22 a tofacilitate preventing undesired longitudinal movement of the handle orgrip 22 away from the first end 16 a and facilitates preventing thedrive member, rotatable member or rod 20 from exiting the housing 16.

The system or instrument 10 comprises an end assembly 31 (FIG. 5) ofcomponents. The end assembly 31 comprises a universal joint 51, animplant holder 58 having a threaded projection 60, a universal jointhousing 63 and an abutment member 26 that is pivotally secured to theuniversal joint housing 63 as described later herein. The universaljoint housing 63 has a tubular portion 63 a that is received in the end16 b of housing 16 until a surface 63 b engages an end 16 b 1 (FIG. 1B).A cylindrical bearing sleeve 63 c is press-fit into the end 16 b duringassembly and the end assembly 31 may be welded or secured in the end 16b by conventional means.

In one embodiment, the universal joint 51 comprises a support shaft 70having an end member 72 (FIG. 5) having an integral cylindrical radialbearing surface 72 a that defines or provides a bearing and an alignerfor becoming operatively associated with and/or engaging at least aportion of an internal wall 63 d of the universal joint housing 63 inorder to retain the universal joint housing 63 in a generally centrallylocated and aligned position within the housing 16.

Referring to FIGS. 3A and 5, note that an end 65 of the universal jointhousing 63 comprises a tubular wall portion 28 having a first surface orwall 28 a and a generally opposing second surface or wall 28 b. Thefirst surface 28 a and second surface 28 b comprise a pair of cut-outareas 32 and 34, respectively. The cut-out areas 32 and 34 are adaptedto define or comprise a pair of generally cylindrical projections orpivot pins 36 and 38, respectively. Note that the cylindricalprojections or pivot pins 36 and 38 are coaxial along axis A and extendor project from the surfaces or walls 28 a and 28 b a common distance D1as shown in FIG. 3A.

The surgical instrument 14 further comprises the abutment member 26mentioned earlier that is pivotally fixed or secured to the universaljoint housing 63. In this regard and as illustrated in FIGS. 3A and 5,the abutment member 26 comprises a pair of flanges 40 and 42. Theflanges 40 and 42 comprise generally cylindrical inner walls 40 a and 42a which define generally cylindrical openings 44 and 46, respectively.The generally cylindrical openings 44 and 46 receive the projections orpivot pins 36 and 38, respectively, thereby enabling the abutment member26 to pivot about the axis A (FIG. 5).

The abutment member 26 comprises a pair of generally U-shaped cut-outareas 48 and 50 defined by walls 52 and 54, respectively. The flanges 40and 42 have generally curved walls 40 b (FIG. 5) and 42 b respectively,that are complementarily shaped and received in the cut-out areas 48 and50. The flanges 40 and 42 are then welded, adhered or otherwise securedto the abutment member 26 after the cylindrical openings 44 and 46 aremounted on the projections or pivot pins 36 and 38, thereby pivotallysecuring and retaining the abutment member 26 to the universal jointhousing 63 that is inserted and mounted into the end 16 b of housing 16.It should be understood that the inner diameter of the generallycylindrical inner walls 40 a and 42 a is slightly larger than the outerdiameter of the projections or pivot pins 36 and 38 so as to permit somelimited “play” and longitudinal movement of the abutment member 26 inthe direction of double arrow C (FIG. 5). This feature enables aposition of the abutment member 26 to be pivoted or moved about theabutment member axis A and with respect to the second end 16 b in amanner described later herein.

Referring back to FIGS. 2A and 2B, the drive member, rotatable member orrod 20 has a second end 20 b that is received in an aperture 70 a (FIG.5) defined by wall 70 b, thereby providing a connector or coupler forrotatably coupling the grip 22 to the universal joint 51 that issituated in the interior housing area 30.

The surgical instrument 10 further comprises the universal joint 51which will now be described. The universal joint 51 has an implantholder 58 having the threaded projection 60, as best illustrated inFIGS. 2A-5. An end 63 e (FIG. 5) of the universal joint housing 63comprises an interior slot wall 62 (FIGS. 3A and 3B) that defines agenerally arcuate and elongated slot 64 that is in communication withthe interior housing area 30 (FIG. 5) mentioned earlier herein. Afterthe abutment member 26 is pivotally secured and mounted to the secondend 63 e in the manner described earlier, an abutment member aperture66, which is defined by an abutment member wall 68 (FIG. 3A), becomesaligned with and in communication with the slot 64. When the surgicalinstrument 10 is assembled, the threaded projection 60 is received inthe slot 64 and in abutment member aperture 66 as best shown in FIGS.2A, 2B, 4, 6 and 7A-7F.

In the illustration being described and as best illustrated in FIG. 3B,notice that the slot 64 is asymmetrical about an imaginary plane IP thatis generally transverse to a longitudinal axis D (FIG. 4) of theuniversal joint housing 63 and in a direction that is generallyperpendicular to the direction to the axis E (FIG. 3B) of the slot 64.This enables and facilitates pivotal movement of the abutment member 26,threaded projection 60 and implant 12 in a first direction to a maximumfirst angle θ and a second direction to a maximum second angle φ, asillustrated in FIGS. 7C, 7E and 7D, 7F, respectively. Note that in oneembodiment, the first angle θ is less than the second angle φ (as viewedin FIG. A), which permits lesser pivotal movement in the first directioncompared to the second direction. Notice that the slot 64 permits nearlyninety degrees (90°) of pivotal movement of the threaded projection 60in an arc or projection of a circle to the angle φ. In one embodiment,the angles θ and φ range from about 20 degrees to about 90 degrees,respectively, as shown in FIGS. 7E and 7F. In another embodiment, therange could be zero degrees to 90 degrees. In the later embodiment, theleft side of slot 64 (as viewed in FIGS. 7A-7E) would be shortened sothat surface 61 of the threaded projection 60 would abut the end of slot64 and extend straight down as viewed in the FIG. 7H.

As previously mentioned, the surgical instrument 10 comprises the jointor universal joint 51 that operatively couples the drive member,rotatable member or rod 20 and the implant holder 58 to permit andenable rotational movement of the implant holder 58 before, during andafter the abutment member 26 or threaded projection 60 is pivoted ormoved, for example, from a home position (such as the exemplary positionillustrated in FIG. 7A) to a pivoted or desired position (such as theexemplary position illustrated in FIGS. 7C and 7F). The threadedprojection 60 has a threaded projection axis F (FIGS. 7C-7D) that isgenerally coaxial with the drive member or rotatable member axis D (FIG.4) when in the home position, but when it is in the pivoted position,the axis F is not coaxial with the axis D (as illustrated in FIGS. 7Cand 7D).

Notice that the ball support 72 of the universal joint 51 is coupled orfixed to an end 20 a of the drive member, rotatable member or rod 20. Inone embodiment, the joint or universal joint 51 comprises the ball 74and a generally mating socket 59. The socket 59 is integral ormonolithic with the threaded projection 60 and defines a head thereof.The ball 74 comprises a first internal wall 78 a (FIG. 9B), a generallyopposing second wall 78 b and connecting walls 78 c and 78 d thatcooperate to define a butterfly or bow tie aperture or slot 80 as bestillustrated in FIGS. 7A-7F, 8A and 8B. The butterfly or bow tie apertureor slot 80 may be machined, milled and/or drilled into the ball 74. Inthe illustration being described and as best shown in FIG. 9D, note thata width W1 of the butterfly aperture or slot 80 is substantially smallerthan a length L1 (FIG. 8A) of the butterfly or bow tie aperture or slot80.

FIG. 8B is a view showing an outline of the butterfly or bow tieaperture or slot 80 in the head 74. Notice that the butterfly or bow tieaperture or slot 80 extends completely through the ball 74 as shown inFIG. 8 and is generally circular in cross section at is midway point anddefines a midway aperture 80 a FIG. 9D). A pivot pin 84 pivotallycouples the socket head 59 to the ball 74 as shown in FIGS. 7A-7F and9A-9D. A circumference or dimension of the midway aperture 80 aapproximately midway through the butterfly aperture or slot 80 issmaller than a circumference of the pivot pin 84. Thus, the midwayaperture 80 a circumferential dimension is slightly larger than acircumference of the pivot pin 84 to facilitate pivoting movement of thesocket or head 59 with respect to the ball 74.

Returning to FIGS. 4-6 and as mentioned earlier, the head or socket 59of the implant holder 58 is pivotally coupled to the ball 74 with thepivot pin 84 that is received in the butterfly aperture or slot 80. Itis important to note that the pivot pin 84 is not coupled to the housing16, but rather, couples the ball 74, which is at the end 70 c of theball support 70, to the head or socket 59 of implant holder 58. As willbe described in more detail later herein, a user rotates the grip 22which causes rotation of the drive member, rotatable member, or rod 20.The ball 74 rotation causes the walls 78 a (FIGS. 9B and 9D) and 78 b todrive and apply rotation torque or rotational movement to the pivot pin84 which, in turn, causes the head or socket 59 of the implant holder 58and threaded projection 60 to rotate. The threaded projection 60rotation enables the user to screw and unscrew the threaded projection60 into a threaded aperture 12 a of the implant 12 to fix or secure theimplant 12 to the instrument. It is important to understand that thisrotation can occur before, during and after the threaded projection 60or implant 12 has been pivoted to the pivoted or desired position aspermitted by the universal joint 51.

Advantageously, the walls 78 a and 78 b that cooperate to define thebutterfly aperture or slot 80 cooperate with the pivot pin 84 tosubstantially simultaneously enable and permit pivotal and rotationalmovement of the implant holder 58 and the threaded projection 60 byenabling the pivot pin 84 to pivot in the butterfly aperture or slot 80in response to a pivotal movement of the implant 12, threaded projection60 or the abutment member 26. The joint or universal joint 51 is adaptedto also permit rotation of the implant holder 58 and threaded projection60 before, during and after such pivoting.

Thus, the joint or universal joint 51 is adapted to permit a looseningof the implant 12 on the implant holder 58 so that the implant holder 58may be pivoted or moved to a desired position (for example, from theposition shown in FIG. 1A to the position shown in FIG. 1B) and alsobeing responsive to rotational movement of the drive member, rotatablemember or rod 20 to cause the threaded projection 60 to be screwed andtightened into the implant 12 so that it can become clamped, fixed orlocked to the implant holder 58 after the implant holder 58 has beenmoved or pivoted to the desired or pivoted position. Further details ofthe joint or universal joint 51 and the pivotal movement and lockingwill now be described relative to FIGS. 4-7F.

As illustrated in FIGS. 4-7F, the implant holder 58 comprises thethreaded projection 60 which, when assembled into the universal jointhousing 63, passes through the slot 64 (FIG. 3B) and through theaperture 66 of the abutment member 26. The head or socket 59 of theimplant holder 58 receives and is secured to the ball 74 with pivot pin84 as mentioned earlier. The head or socket 59 of the implant holder 58comprises a generally spherical inner wall 59 a and a generallyspherical outer wall 59 b as best illustrated in FIGS. 5 and 6. The end63 b of the universal joint housing 63 comprises a generally sphericalinner wall 63 b 1 (FIG. 6) that defines a generally spherical seat area90 (FIG. 6) that receives the head or socket 59 of the implant holder 58such that the generally spherical outer wall 59 b of the implant holder58 becomes seated against or operatively associated with the generallyspherical inner wall 63 b 1. In this regard, a shape of the generallyspherical outer wall 59 b generally complements the generally sphericalshape of the spherical inner wall 63 b 1 to permit smooth anduninterrupted rotation movement of the implant holder 58 about its axis,as well as pivotal and rotational movement of the threaded projection 60in the slot 64.

The ball 74 is also generally spherical as shown and is received in aseat 91 (FIG. 6) defined by the generally spherical inner wall 59 a ofthe head or socket 59.

The head or socket 59 comprises a pair of generally cylindrical innerwalls 86 (FIG. 5) and 88 that define apertures 92 and 94, respectively.After the ball 74 is received in the seat 91 defined by the generallyspherical inner wall 59 b, the pivot pin 84 may be placed into thebutterfly aperture or slot 80 (FIG. 9) and in apertures 92 and 94 topivotally and rotationally couple the implant holder 58 to the ball 74.In the illustration being described, the apertures 92 and 94 are sizedto enable the pivot pin 84 to be press-fit therein. Alternatively, thepivot pin 84 may also be spot welded or secured in place by other means,such as an adhesive. As mentioned earlier herein, it is important tonote that the pivot pin 84 does not extend axially into any wall ofeither the universal joint housing 63 or the housing 16 so that the heador socket 59 of the implant holder 58 may freely rotate and pivot withinthe end 63 b 1 of the universal joint housing 63 to enable the threadedprojection 60 to be pivoted, screwed into, unscrewed or loosened andtightened into the implant 12.

The end assembly 31 is assembled as described, with the universal joint51 being situated in the universal joint housing 63, with the threadedprojection 60 extending through the slot 64 of end 63 b and throughaperture 60 in the abutment member 26. The ball support 70 is fixed tothe drive member, rotation member or rod 20, which is also secured togrip 22, inside housing 16. The end assembly 31 is then inserted andfixed, such as be a press-fit, weld, adhesive or the like, into end 16 bof housing 16.

As illustrated in FIGS. 7A-7F, the implant 12 comprises the implantfemale threaded aperture 12 a that threadably receives the threadedprojection 60 of the implant holder 58. In one embodiment, the abutmentmember 26 comprises a generally arcuate surface 26 a that complements ashape of an outer surface 12 b of the implant 12 and defines a seat area98 for receiving the arcuately-shaped surface 12 b of the implant 12 asshown. The second end 63 b of the universal joint housing 63 becomesassociated with the end 16 b of housing 16 and comprises a plurality ofserrations or teeth 100 (FIG. 3A) that mate with a plurality ofserrations or teeth 102 (FIG. 2) on the abutment member 26 as shown. Inthe illustration being described, the teeth 100 (best illustrated inFIG. 3A) cooperate with the teeth 102 (best illustrated in FIG. 2) ofthe abutment member 26 to lock these components together and preventpivotal movement of the implant 12 and the abutment member 26 relativeto the end 16 b of the housing 16 after the implant 12 is clamped, fixedor locked thereto as described herein.

FIGS. 7A and 7C illustrate the first position or home position mentionedearlier wherein the axis F of the threaded projection 60 is generallycoaxial with the axis D of the drive member, rotatable member, or rod20. When the user rotates the grip 22 in a screwing or clockwisedirection relative to the end 16 a of the housing 16, a simultaneous andcorresponding rotational movement of the drive member 20 and ball 74occurs which rotatably drives the pivot pin 84 and head or socket 59. Inresponse, the implant holder 58 and the threaded projection 60 arerotated, thereby causing the threaded projection 60 to be screwed intothe female threaded aperture 12 a. Continued rotation or screwing causesthe implant surface 12 c of implant 12 to move in the direction of arrowG (FIG. 7A) toward and engage surface 26 a of abutment member 26 whichis urged to move toward the second end 63 of the housing 16. As thethreaded projection 60 is screwed further, it causes the ball 74 to movetoward the implant 12 and tightened against the spherical inner wall 16b 1 (FIG. 7B) of second end 16 b until the head or socket 59 of thegenerally spherical outer wall 59 b engages the inner spherical surfaceor wall 16 b 1 of the housing 16, and the teeth 100 engage teeth 102 toclamp, fix or lock the implant 12 in the abutment member 26 to the end63 b of housing 63.

Advantageously, the implant 12 and outer wall 59 b of the head or socket59 cooperate to define a clamp for clamping of the wall 59 b of the heador socket 59, wall 63 b 1 of universal joint housing 63 and abutmentmember 26 together. As mentioned earlier, the teeth 102 on abutmentmember 26 engage teeth 100 on the second end 63 b of universal jointhousing 63 to rigidly lock and clamp the abutment member 26 to thesecond end 63 b, thereby locking the implant 12 to the surgicalinstrument 10.

If it is desired to change a position or pivot the implant 12 or theabutment member 26 (for example, to the position shown in FIGS. 1B, 1D,7C-7F), then the grip 22 is rotated in a counterclockwise directionwhich causes the threaded projection 60 to be unscrewed or loosened fromthe threaded aperture 12 a at end 12 c of the implant 12. In thisregard, note that the generally arcuate surface 26 a of the abutmentmember 26 is adapted and dimensioned to hold the implant 12 generallystationary in the spherical seat area 90 when the threaded projection 60is rotated either clockwise or counterclockwise. (David—True?) Althoughnot shown, the generally arcuate surface 26 a of the abutment member 26may comprise serrations or be otherwise roughened to further facilitatepreventing relative movement between the implant 12 and the abutmentmember 26 when the drive member, rotatable member or rod 20 is rotated.

FIGS. 1B, 1D and 7C-7F illustrate pivotal movement of the implant holder58, threaded projection 60 and implant 12 which will now be described.Note in FIG. 7C that the implant holder 58 has been pivoted or moved theangle θ to its leftmost position (as viewed in the figure). As mentionedearlier herein, the slot 64 is not symmetrical about a centerline of theimaginary plane IP (FIG. 3B) so that the extent of the pivotal movementof the abutment member 26 through the angle θ, illustrated in FIG. 7C,is less than the movement to the angle φ because the ends of the slot 64limit movement of the threaded projection 60 between the angles θ and φ.The butterfly aperture or slot 80 (FIGS. 8A and 8B) in the ball 74 ofthe joint or universal joint 51 permits the pivot pin 84 and implantholder 58 to pivot between the angles θ and φ to the desired or pivotedposition. It should be understood that the relationship of the abutmentmember 26 about its axis A (FIG. 3A) is along a consistent arc relativeto the end 16 b of the housing 16, which is guaranteed or assured by theflanges 40 and 42 which couple the abutment member 26 to the pivot pins36 and 38 (FIG. 3A). As mentioned earlier, in one preferred embodiment,the projection member 60 of the implant holder 58 can pivot a total ofapproximately 90 degrees in angle φ, but only about zero degrees forangle θ. In another embodiment, the range is approximately 90 degrees inangle φ, but only about 20 degrees in angle θ.

As illustrated in FIGS. 7A, 7C and 7D, there is some play in thelongitudinal movement of the abutment member 26 relative to the secondend 16 b so that the teeth 102 on the abutment member 26 may by spacedfrom and ride or pass over the teeth 100 at the end 63 b of theuniversal joint housing 63 when the threaded projection 60 is unscrewedor loosened from the implant 12. This facilitates or enables the angularor pivotal position of the abutment member 26 relative to the second end63 b to be changed relatively easily.

The head or socket 59 of the implant holder 58 is rotatable in 360degrees about the axis F of the threaded projection 60. Note that apivot point PP (FIG. 7C) of the pivot pin 84 lies generally at a centerof the ball 74. The abutment member 26 has the abutment member pivotaxis A (FIG. 3A) which generally lies in the same imaginary plane as thepivot point PP of ball 74. The alignment of the axis A in this imaginaryplane facilitates enabling the axis F of the threaded projection 60 toremain generally perpendicular to an imaginary tangent line TL (FIG. 7D)during pivotal movement of the threaded projection 60 and the abutmentmember 26.

As illustrated in FIGS. 1B, 1D, 7D and 7F, the user, such as a surgeon,positions or pivots the implant 12 and the abutment member 26 in thedesired pivoted or angled position after loosening or unscrewing of thethreaded projection 60 in the implant 12 by rotating grip 22 in anunscrewing direction, which is a counterclockwise direction in theillustration. In this example, it is assumed that the implant 12 ispivoted to the right as shown in FIGS. 1B, 1D, 7D and 7F. Once theimplant 12 is pivoted to the desired position, the user or surgeonrotatably drives the handle or grip 22 (FIG. 1) in a clockwise orscrewing direction which rotatably drives the ball 74 of the joint oruniversal joint 51 and correspondingly causes rotation of the implantholder 58 and the threaded projection 60. This causes the threadedprojection 60 to become screwed into the threaded aperture 12 a ofimplant 12. As mentioned earlier, this screwing action causes theimplant 12 to move or be urged or driven in the direction of arrow E(FIG. 7D) until the end 12 c engages the arcuate support surface 26 a ofthe abutment member 26. The screwing also causes the abutment member 26to be driven toward end 63 b and the abutment member teeth 102 to bedriven toward and mate with the teeth 100 on end 63 b. Note thatgenerally spherical outer surface 59 b of head or socket 59 isresponsively driven toward implant 12 until it clamps against thegenerally spherical inner wall 63 b 1 (FIG. 6), thereby causing aclamping, locking or fixing of the ball 74, head 59, end wall 63 b,projection member 60 and implant 12 together. This also fixes theimplant 12 in a locked position on the instrument 10.

It is important to note that the joint or universal joint 51 enables thedrive member, rotatable member, or rod 20 to cause the implant 12 tobecome clamped, fixed or locked to the implant holder 58 by enabling thedrive member, rotatable member, or rod 20 to rotatably drive theuniversal joint 51, ball 74, head or socket 59, implant holder 58 andpivotal threaded projection 60 through a pivot of the head or socket 59and the threaded projection 60. FIGS. 9A-9C, which are shown andillustrated without the housing 16 and abutment member 26 for ease ofdescription and illustration, show this feature. For example, when thethreaded projection 60 of implant holder 58 is in the angled, pivoted ormoved to the desired position, such as the position shown in FIG. 9A,the threaded projection 60 may be rotated while into the pivoted ordesired position by rotating the handle or grip 22. The drive member,rotatable member, or rod 20 may be rotated by rotating the handle orgrip 22 to correspondingly rotate the ball 74 and socket 59, therebycausing a rotation in the threaded projection 60 about its axis F.

FIG. 9B illustrates a cross-sectional view of the universal joint 51after the implant holder 58 and the threaded projection 60 have beenrotated either 90 degrees or 270 degrees from the position shown in FIG.9A (which would cause the pivot pin 84 axis PPA to project or extendperpendicular to the drawing sheet). FIG. 9C illustrates a furtherrotation of the implant holder 58 and threaded projection 60 to aposition that is 180 or 360 degrees of rotation relative to the positionshown in FIG. 9A.

Advantageously, a feature of the embodiments being described is that thejoint or universal joint 51 is adapted to permit both pivotal androtational movement of the implant holder 58 and the threaded projection60 using a single connector drive member, rotatable member or rod 20.The cooperation of the components, namely the universal joint 51, ball74, implant holder 58, housing 16 and abutment member 26 enable theloosing of the implant holder 58 so that the implant 12 can be pivotedor moved and then tightening of the implant 12 to cause the componentsto be clamped, fixed or locked together using a single drive memberassembly. The pivotal and rotational movement is achieved using thesingle drive member, rotatable member or rod 20 having the universaljoint 51, which has been found to improve that performance of theinstrument 10 while reducing its complexity.

Although the illustration being described shows a ball 74 and head orsocket 59, it does not have to be a strict ball and socket configurationand the components 74 and 59 could have other configurations providedthat they permit and allow the pivotal and rotational movement asdescribed herein.

Advantageously, the implant holder 58 shown and described permits theuse of standard cages. In other words, a custom cage having a customjoint is not required. The cage size can change as well. This ispermitted because the pivot point is located in the holder, not thecage. This feature also results in the graft area in the implant 12 tobe maintained and not reduced as was the case with some prior artdevices.

While the system, apparatus and method herein described constitutepreferred embodiments of this invention, it is to be understood that theinvention is not limited to this precise system, apparatus and method,and that changes may be made therein without departing from the scope ofthe invention which is defined in the appended claims.

What is claimed is:
 1. A surgical instrument for inserting an implant,the surgical instrument comprising: a housing having a first end and asecond end; a rotatable member rotatably positioned in said housing,said rotatable member having an elongated member comprising a gripassociated with said first end, an implant holder having a securingmember that extends through said second end and that is adapted toreceive and hold said implant; a universal joint coupling said implantholder and said elongated member; and said universal joint situatedbetween said grip and said implant holder, said universal joint beingadapted to permit a user to rotatably drive said implant holder whensaid implant holder is in a pivoted position.
 2. The surgical instrumentas recited in claim 1 wherein said implant comprises a threaded opening,said securing member comprising a threaded projection, said universaljoint being adapted to permit said threaded projection to be rotated andscrewed into said implant while in said pivoted position.
 3. Thesurgical instrument as recited in claim 2 wherein said universal jointcomprises a ball and socket.
 4. The surgical instrument as recited inclaim 3 wherein said second end of said housing comprises a second endinner surface and a second end outer surface, said socket comprises ahead having an outer surface and said threaded projection that extendsthrough said second end for securing to said implant; wherein saiduniversal joint is adapted to permit the user to rotate said threadedprojection while in said pivoted position in order to clamp or lock saidimplant in a clamped, fixed or locked position to the surgicalinstrument.
 5. The surgical instrument as recited in claim 4 wherein thesurgical instrument further comprises: an abutment member associatedwith said second end for providing an abutment surface against whichsaid implant can be driven in order to clamp, fix or lock said implantinto said clamped, fixed or locked position.
 6. The surgical instrumentas recited in claim 5 wherein said abutment member has an abutmentmember pivot axis and said implant holder comprises an implant holderpivot axis, said abutment member pivot axis being coaxial with saidimplant holder pivot axis.
 7. The surgical instrument as recited inclaim 5 wherein said abutment member is pivotable with respect to saidsecond end and comprises a first surface associated with said second endof said housing and an abutment surface, said abutment surface beinggenerally arcuate.
 8. The surgical instrument as recited in claim 7wherein said implant comprises an implant surface that is generallyarcuate, said implant surface complementing and mating with saidabutment surface when said implant is clamped, fixed or locked onto thesurgical instrument.
 9. The surgical instrument as recited in claim 5wherein said abutment member comprises abutment member teeth orserrations to facilitate clamping, fixing or locking said implant insaid locked position.
 10. The surgical instrument as recited in claim 9wherein said second end of said housing comprises housing teeth orserrations that mate with said abutment member teeth or serrations toclamp, fix or lock said implant to said instrument.
 11. The surgicalinstrument as recited in claim 7 wherein said abutment surface comprisesabutment member teeth or serrations to facilitate clamping, fixing orlocking said implant to the surgical instrument.
 12. The surgicalinstrument as recited in claim 11 wherein said implant comprises implantteeth or serrations that mate with said abutment member teeth orserrations.
 13. The surgical instrument as recited in claim 1 whereinsaid universal joint comprises a ball joint that is rotatable withinsaid housing.
 14. The surgical instrument as recited in claim 13 whereinsaid ball joint comprises: a socket having said implant holder; a ballhaving at least one aperture; at least one pivot pin received in said atleast one aperture and mounted in said socket to pivotally couple saidsocket to said ball; said pivot pin rotatably driving said socket inresponse to rotation of said rotatable member and permitting saidimplant holder to pivot relative to said ball so that said securingmember may be pivoted from a first position to said pivoted position.15. The surgical instrument as recited in claim 14 wherein an axis ofsaid securing member is coaxial with a longitudinal axis of saidrotatable member when in said first position, but is not co-axial whenin said pivoted position.
 16. The surgical instrument as recited inclaim 1 wherein said second end comprises a slot for permitting saidsecuring member to extend through said second end and also permittingsaid securing member to pivot in said slot.
 17. The surgical instrumentas recited in claim 14 wherein said at least one aperture is a butterflyaperture extending through said ball, said butterfly aperture beingadapted to receive said pin and to permit said socket to pivot about anaxis of said pin and to be rotatable driven by said pin.
 18. Thesurgical instrument as recited in claim 14 wherein said socket comprisesa spherical recess and a spherical outer wall, said spherical outer wallengaging an inner wall of said second end and becoming clamped againstsaid inner wall of said second end when said implant holder is clamped,fixed or locked to said implant.
 19. The surgical instrument as recitedin claim 14 wherein said at least one pivot pin has a pivot pin axisthat is generally perpendicular to a longitudinal axis of said rotatablemember.
 20. The surgical instrument as recited in claim 19 wherein saidpivot pin access and said longitudinal axis of said rotatable memberintersect.
 21. The surgical instrument as recited in claim 1 whereinsaid universal joint is adapted to permit both a loosening of saidimplant on said implant holder so that a position of said implant on thesurgical instrument may be adjusted or moved to said pivoted positionand a rotation of said securing member to cause said implant to beclamped, fixed or locked onto the surgical instrument.
 22. The surgicalinstrument as recited in claim 21 wherein said securing member is athreaded projection that is received in a threaded aperture in saidimplant.
 23. The surgical instrument as recited in claim 11 wherein thesurgical instrument further comprises said implant.
 24. A surgicalimplant system comprising: an implant; a surgical instrument comprising:a housing: a drive member rotatably mounted within said housing; animplant holder; a joint rotatably and pivotally coupling said drivemember to said implant holder; said joint being adapted to permit aloosing of said implant on said implant holder so that said implantholder may be pivoted or moved to a desired position and beingresponsive to rotational movement of said drive member to enable saidimplant to be loosened and pivoted and to cause said implant to becomeclamped, fixed or locked to said implant holder after said implantholder is pivoted or moved to said desired position.
 25. The surgicalimplant system as recited in claim 24 wherein said implant holdercomprises a pivotable threaded projection that extends through an end ofsaid housing, said joint permitting said drive member to rotatably drivesaid pivotable threaded projection through a pivot of said pivotablethreaded projection.
 26. The surgical implant system as recited in claim24 wherein said joint is a universal joint.
 27. The surgical implantsystem as recited in claim 24 wherein said implant holder comprises ahead; an end of said drive member being received in said head andsecured thereto with a pivot pin in order to permit said head to pivotabout an axis of said pivot pin and also to permit said pivot pin torotatable drive said head in response to rotation of said drive member.28. The surgical implant system as recited in claim 27 wherein said headcomprises an integral threaded projection.
 29. The surgical implantsystem as recited in claim 24 wherein said head comprises a socket andsaid end of said drive member comprises a ball.
 30. The surgical implantsystem as recited in claim 24 wherein said surgical instrument isadapted to permit loosening and tightening of said implant so that aposition of said implant may be changed from a first position to saiddesired position.
 31. The surgical implant system as recited in claim 25wherein said implant comprises a threaded opening, said implant holdercomprises said pivotable threaded projection, said joint being adaptedto permit said threaded projection to be rotated and screwed into andout of said threaded opening in said implant after said pivotablethreaded projection has been pivoted or moved to said desired position.32. The surgical implant system as recited in claim 27 wherein saidsecond end of said housing comprises a second end inner surface, saidhead having an outer surface and said pivotable threaded projection thatextends through said second end for securing to said implant; whereinsaid joint is adapted to permit the user to rotate said pivotablethreaded projection while in said desired position in order to clamp,fix or lock said implant in a clamped, fixed or locked position.
 33. Thesurgical implant system as recited in claim 32 wherein the housingfurther comprises: an abutment member associated with said second endfor providing an abutment surface against which said implant can bedriven in order to clamp, fix or lock said implant into said clamped,fixed or locked position.
 34. The surgical implant system as recited inclaim 33 wherein said abutment member is pivotably coupled to saidhousing and an abutment surface, said abutment surface being generallyarcuate.
 35. The surgical implant system as recited in claim 34 whereinsaid abutment member has an abutment member pivot axis and said implantholder comprises an implant holder pivot axis, said abutment memberpivot axis being coaxial with said implant holder pivot axis.
 36. Thesurgical implant system as recited in claim 34 wherein said second endof said housing defines a generally arcuate slot, said pivotablethreaded projection has a pivotable threaded projection axis thatremains generally perpendicular to a tangent of said generally arcuateslot when it is moved or pivoted in said generally arcuate slot.
 37. Thesurgical implant system as recited in claim 34 wherein said implantcomprises an implant surface that is generally arcuate, said implantsurface complementing and mating with said abutment surface when saidimplant is clamped, fixed or locked onto the surgical instrument. 38.The surgical implant system as recited in claim 33 wherein said abutmentmember comprises abutment member teeth or serrations to facilitateclamping, fixing or locking said implant in said locked position. 39.The surgical implant system as recited in claim 38 wherein said secondend of said housing comprises housing teeth or serrations that mate withsaid abutment member teeth or serrations to clamp, fix or lock saidimplant to said instrument.
 40. The surgical implant system as recitedin claim 33 wherein said abutment member is pivotally coupled to saidhousing.
 41. The surgical implant system as recited in claim 32 whereinsaid second end comprises a slot adapted to permit said pivotablethreaded projection to pivot.
 42. The surgical implant system as recitedin claim 41 wherein said slot is asymmetrical with respect to animaginary longitudinal plane.
 43. The surgical implant system as recitedin claim 33 wherein said second end comprises a slot adapted to permitboth said abutment member and said pivotable threaded projection topivot.
 44. The surgical implant system as recited in claim 33 whereinsaid abutment surface comprises abutment member teeth or serrations tofacilitate clamping, fixing or locking said implant to the surgicalinstrument.
 45. The surgical implant system as recited in claim 44wherein said implant comprises implant teeth or serrations that matewith said abutment member teeth or serrations.
 46. The surgical implantsystem as recited in claim 24 wherein said joint comprises a ball jointthat is rotatable within said housing.
 47. The surgical implant systemas recited in claim 46 wherein said ball joint comprises: a sockethaving said implant holder; a ball having at least one aperture; atleast one pivot pin received in said at least one aperture and mountedin said socket to pivotally couple said socket to said ball; said pivotpin rotatably driving said socket in response to rotation of said drivemember and permitting said implant holder to pivot relative to said ballso that said implant holder may be pivoted from a first position to saiddesired position.
 48. The surgical implant system as recited in claim 47wherein said at least one aperture is a butterfly aperture extendingthrough said ball, said butterfly aperture being adapted to receive saidpin and to permit said socket to pivot about an axis of said pin and tobe rotatable driven by said pin.
 49. The surgical implant system asrecited in claim 27 wherein said head comprises a spherical recess and aspherical outer wall, said spherical outer wall engaging an inner wallof a second end of said housing and becoming clamped against an innerwall of said second end when said implant holder is clamped, fixed orlocked to said implant.
 50. The surgical implant system as recited inclaim 47 wherein said at least one pivot pin has a pivot pin axis thatis generally perpendicular to a longitudinal axis of said drive member.51. The surgical implant system as recited in claim 50 wherein saidsurgical instrument further comprises an abutment member pivotablycoupled to said housing, said abutment member having an abutment memberaxis that lies in a common plane with said pivot pin axis.
 52. Thesurgical implant system as recited in claim 50 wherein said pivot pinaccess and said longitudinal axis of said drive member intersect. 53.The surgical implant system as recited in claim 24 wherein said joint isadapted to permit both a loosening of said implant on said implantholder so that a position of said implant on the surgical instrument maybe adjusted or moved to said desired position and a rotation of saidimplant holder to cause said implant to be clamped, fixed or locked ontothe surgical implant system.
 54. An surgical instrument for inserting animplant, comprising: an implant holder; a drive member for rotatablydriving said implant holder; and a joint adapted to permit said drivemember to rotatably drive said implant holder through a pivot thereof.55. The surgical instrument as recited in claim 54 wherein said joint isa universal joint.
 56. The surgical instrument as recited in claim 55wherein said universal joint comprises: a threaded projection forscrewing into the implant, said threaded projection comprising a headadapted to define a socket; said drive member having a ball adapted tobe received in said socket; said ball and socket cooperating and adaptedto permit said threaded projection to pivot and to be rotatably drivenby said drive member before, during or after said pivot.
 57. Thesurgical instrument as recited in claim 56 wherein said ball has abutterfly aperture, said universal joint further comprising a pivot pincoupling said butterfly aperture to said head to permit pivotal movementof said head with respect to said ball and further permitting said ballto rotatably drive said head.
 58. The surgical instrument as recited inclaim 54 wherein said instrument further comprises an abutment memberadapted to receive said implant.
 59. The surgical instrument as recitedin claim 58 wherein said instrument comprises a housing, said abutmentmember being pivotally connected to said housing and pivoting about anaxis that lies in an imaginary plane in which a pivot axis of saidthreaded projection lies.
 60. The surgical instrument as recited inclaim 54 wherein said surgical instrument comprises a joint housing forreceiving said joint, said instrument further comprising: an generallytubular instrument housing having a first end and a second end; a gripcoupled to said drive member for rotatably driving said drive member,said grip being associated with said first end; said joint housing beingadapted to receive said joint and be mounted to said first end.
 61. Thesurgical instrument as recited in claim 60 wherein said joint is auniversal joint.
 62. The surgical instrument as recited in claim 61wherein said universal joint comprises: a threaded projection forscrewing into the implant, said threaded projection comprising a headadapted to define a socket; said drive member having a ball adapted tobe received in said socket; said ball and socket cooperating and adaptedto permit said threaded projection to pivot and to be rotatably drivenby said drive member before, during or after said pivot.
 63. Thesurgical instrument as recited in claim 62 wherein said ball has abutterfly aperture, said universal joint further comprising a pivot pincoupling said butterfly aperture to said head to permit pivotal movementof said head with respect to said ball and further permitting said ballto rotatably drive said head.